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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97713
Device Problems Overheating of Device (1437); Malposition of Device (2616)
Patient Problems Burning Sensation (2146); Complaint, Ill-Defined (2331); Skin Inflammation (2443)
Event Date 06/06/2018
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 37791, serial#: unknown, product type: recharger. Other relevant device(s) are: product id: 37791, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Information was received from the manufacturer's representative regarding patient who was implanted with a neurostimulator for spinal cord stimulation - failed back surgery syndrome/ spinal pain. It was reported that the patient felt that the antenna got hot to the point where it felt like it was burning their skin. Patient did not see thermometer icon when recharging. The rep reported that the patient has not seen the thermometer icon at all. Tss also collected insr stats and reviewed information with the rep - last 6 sessions show average antenna temperature never reached 38. 3 degrees c and average was around 35-36 degrees c and patient typically charged for several hours at a time, typically around 3. 5-4 hours. It was reported that the patient has gotten blisters before however no reports of blisters today. Ins was very superficial to the point where it looked uncomfortable as there were some areas where the ins was protruding through the patient's skin. No further complications were reported/anticipated.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Additional information was reported that the cause of the burning is not known. The patient was told to charge for shorter periods at a time and to have a piece of clothing between their skin and the recharger. The patient has not called the rep with any additional complaints so they assume the issue was resolved. No further information was reported.

 
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Brand NameSURESCAN
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key9616493
MDR Text Key176663304
Report Number3004209178-2020-01550
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/14/2016
Device MODEL Number97713
Device Catalogue Number97713
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/14/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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